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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE

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TOMTEC IMAGING SYSTEMS GMBH TOMTEC-ARENA TTA2 IMAGE REVIEW AND QUANTIFICATION SOFTWARE Back to Search Results
Model Number TTA2
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation is underway to determine the root cause of the issue. Results of the investigation will be included in a follow up report upon its completion.
 
Event Description
The workflow triggering the event involves multiple systems: measurements are done on the ultrasound modality and then studies are sent in to enterprise imaging (ei) from agfa. From ei client the studies are opened in tomtec-arena from tomtec and the measurements are then exported via xml file to the cupid system from epic for reporting purpose. In some circumstances it happens that the measurements from the previous patient\study is sent additionally to epic cupid for the current one however with the current patients\study details. The software is used in clinical routine, there was no injury or serious deterioration of health state reported with this event.
 
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Brand NameTOMTEC-ARENA TTA2
Type of DeviceIMAGE REVIEW AND QUANTIFICATION SOFTWARE
Manufacturer (Section D)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85716
GM 85716
Manufacturer (Section G)
TOMTEC IMAGING SYSTEMS GMBH
edisonstrasse 6
unterschleissheim, 85716
GM 85716
Manufacturer Contact
gerald paul
edisonstrasse 6
unterschleissheim, 85716
GM   85716
MDR Report Key9911027
MDR Text Key208329764
Report Number8043836-2020-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K150122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Administrator/Supervisor
Remedial Action Repair
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTTA2
Device Lot Number21.07
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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